Safety Trial of Patient Specific Guides for Lumbar Fusion

NCT ID: NCT04751981

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthopedic Disorder of Spine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient Specific Guide

Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.

Group Type EXPERIMENTAL

Patient Specific Guide

Intervention Type PROCEDURE

For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.

Navigation

Patients randomized into this group will have pedicle screws placed with conventional navigation.

Group Type OTHER

Navigation

Intervention Type PROCEDURE

Conventional navigation will be used to place pedicle screws.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient Specific Guide

For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.

Intervention Type PROCEDURE

Navigation

Conventional navigation will be used to place pedicle screws.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years or over
* Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
* Recently has or requires a CT-scan of the spine
* No previous spine surgery on the level being used for patient specific guides
* Sufficient understanding of the English language or interpretation assistance available.

Exclusion Criteria

* History of alcohol or drug abuse
* History of psychiatric disorders
* Previous spine surgery adjacent or at the level of the surgery
* Unable to read or comprehend the consent form/letter of information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10079

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LUMBAR & SACROILIAC FUSION STUDY
NCT07204288 RECRUITING NA